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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K254042

510(k) cleared

WatchPAT SW

Itamar Medical , Ltd. · Jul 31, 2026 · K254042

FDA cleared the WatchPAT SW from Itamar Medical , Ltd. on Jul 31, 2026 under K254042, a traditional 510(k). The device falls under product code MNR, Ventilatory Effort Recorder, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Dec 16, 2025. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Itamar Medical , Ltd. has one other decision in the tracker over the last 12 months: K250460 (WatchPAT400 (WP400)).

Questions & Answers

What did FDA clear under K254042?

K254042 is the FDA 510(k) for WatchPAT SW, submitted by Itamar Medical , Ltd.. FDA's decision date was Jul 31, 2026, under product code MNR (Ventilatory Effort Recorder).

Who makes the WatchPAT SW?

Itamar Medical , Ltd., based in Caesarea, is the applicant of record for K254042.

How long did the K254042 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Jul 31, 2026, 227 days later.

← All decisions in July 2026

Sources